Under the Health Insurance Portability and Accountability Act (HIPAA), health care organizations such as hospitals, drug testing Institutions, for example, must insure HIPAA compliance by protecting the confidentiality of patients' Medical Records. Audit Agencies involved in auditing patient Medical Records of health care organizations must be qualified in order to perform such audits, and the health organization or Institution must insure that the auditors do not breach the privacy of patients relative to their associated Medical Records. HIPAA requirements severely restrict the capability of health care organizations or Institutions to allow access to individual patient records. Such records are typically stored in large computer memories, and the records may include a large number of patients' Medical Records, or clinical research records, for example, whereby the associated healthcare organization must insure the privacy of such patients' records. Accordingly, any review of such records by an outside service group, such as an Auditing Agency must be from records that are free of the private information of each patient, such as their names, addresses, and so forth.
Healthcare organizations are Institutions ranging from the very small to the very large, and even individual practices, such as a sole practitioner physician, are increasingly implementing electronic Medical Record systems. A variety of database management systems are used to support this capability. Perhaps the most popular, underlying engine is Oracle®, but there are others such as Focus®. Many of the popular database programs have the capability to create database “dumps.” There is a considerable range of choices in the way these dumps can be structured. The capability to output in a standardized “Markup” language is common with Extensible Markup Language (XML) being the currently preferred method. The electronic Medical Record itself and also the electronic clinical research record have defined structures in order to capture laboratory, special investigation, drug administration and medical/nursing progress notes in a structured format. Search Engines, typically, cannot search within databases and cannot index within. Creating a dump in a standardized “Markup” language creates a situation where a Search Engine can index and subsequently search the dumped data.
In order to obtain Federal Drug Administration (FDA) Approval for new drugs, drug companies must conduct clinical trials in accordance with a specific Protocol representing a plan for a course of medical treatment having a precise step-by-step description of the treatment plan associated with the experimental drug. Under FDA rules, clinical trials for a new drug particularly must pass through what are known as Phase 1, 2, and 3 Trials. The
Phase 1 Trials are the earliest trials in the testing of a new drug, and usually involve up to about 30 patients. Phase 1 trials involve clinical or laboratory testing to show that a new treatment might help treat patients having a particular disease. The Phase 1 Trials are conducted to determine relative to the experimental drug, the safe dose range, side effects, how the body copes with the drug, and whether the treatment appears to treat the involved disease. Initially, the first patient to take part in the clinical study will be given a very small dose of the drug. If all goes well, the next person will get a slightly higher dose. With each patient taking part, the dose will gradually be increased, and the effect of each dose must be monitored, with any side effects being recorded. Blood tests and other monitoring will be conducted in order to determine how the drug is affecting the patients involved in the trial, how their bodies cope with the experimental drug, and how their bodies rid themselves of the drug after the dosages are stopped. Many times, people entering Phase 1 trials are healthy individuals, whereby the purpose of the trial is to monitor different dosage levels and side effects, in addition to pharmacodynamics and pharmacokinetics of the drug (how the body metabolizes the drug and how the drug affects the body). Testing is the first to be pursued before the drug can be tested as a potential new treatment for a particular disease to determine the efficacy of the new drug.
Phase 2 Trials are the next to be performed in testing a new drug. Only about 70% of potential new drugs proceed from Phase 1 Trials to Phase 2 Trials. The Phase 2 Trials are typically conducted on patients who all have the same type of disease, or with different types of a particular disease. Phase 2 Trials are conducted to determine whether a new treatment works well enough to pass on to Phase 3 Trials; the types of disease the drug appears to be effective against; increased information pertaining to side effects and how to manage them; and a determination of the most effective doses to utilize. The Phase 2 Trials may involve up to about 50 patients. If the Phase 2 Trial results indicate that prescribed new treatment is as good or better than an existing treatment, the drug will then be moved into Phase 3 Trials.
Phase 3 trials are conducted to measure results obtained with treatment utilizing the newer experimental drug when compared to the best currently available drug/treatment (standard treatment). It should be noted that the clinical studies involving Phases 1 through 3 may also involve other than new drugs, for example, radiotherapy treatments, X-ray or radiation treatments, and so forth. Phase 3 trials usually involve a much larger group of patients, perhaps thousands of patients in many different hospitals and even different countries, in view of the fact that differences in success rates may be small. Accordingly, the results obtained from many patients must be compared in order to show the difference between the treatment with the new drug and the standard drug.
The testing of a new drug, in any of the Phases, requires the maintenance of increasingly larger databases for typically accumulating in a computer memory the testing history for each patient in accordance with the Protocol. The FDA requires that the testing Institution, such as a hospital having a medical research center, work with an outside Audit Agency to insure that the established Protocol for any phase of the drug testing is being complied with. As previously indicated, the research center, hospital, or medical Institution must comply with HIPAA requirements that the privacy be protected for each patient involved in the various drug testing phases. As a result, any access given to personnel of an Audit Agency to the Medical Record system or patient database must have each patient's testing record kept intact while eliminating any information that might permit an auditor to identify the patient.